Medical Device Legal News with Sam Bernstein: Episode 10
Drafting Consumer Breach Notices — From a Litigation Perspective - Unauthorized Access Podcast
IP|Trend: Dust up After the Breach
Hot Topics Roundtable for Fund Managers - Cybersecurity, Valuation, and More
With 2025 barely three weeks old, the US Department of Health and Human Services Office for Civil Rights (OCR) has already announced six enforcement actions for the new year. Particularly significant is the advancement of...more
It’s not immediately obvious why someone would want to disclose a health care test result as part of a job application. But one such request spurred a Pennsylvania entity to provide a lot more than that: it sent her whole...more
The HHS Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying 946,801 people whose protected health information or other personally identifiable information...more
Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more
On May 31, 2024, more than four months after the February 2024 Change Healthcare ransomware attack, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) updated its Change Healthcare FAQs. ...more
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more
The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more
On February 14, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its annual reports to Congress detailing its actions to enforce the privacy, security, and breach notification...more
On April 26, 2024, the Federal Trade Commission (“FTC”) announced it had finalized changes to modernize the Health Breach Notification Rule (the “HBNR”) by clarifying its applicability to health and wellness apps and other...more
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more
On Feb. 16, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published its 2022 Annual Report to Congress. ...more
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more
On July 20, 2023, the Department of Health and Human Services (DHHS) through the Office of Civil Rights (OCR) and the Federal Trade Commission (FTC) issued a joint letter to hospitals and telehealth providers alerting them to...more
The Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) recently published a warning letter that they jointly sent to more than 130 hospital systems and...more
If you are involved with any health information, even if you are not covered by HIPAA, you should be aware of the government’s recent position that there may be serious privacy and serious risks with use of online tracking...more
The Federal Trade Commission and the U.S. Department of Health and Human Services' Office for Civil Rights are cautioning hospitals and telehealth providers about the privacy and security risks related to the use of online...more
On June 30, 2023, Mount Desert Island Hospital (“MDIH”) filed a notice of data breach with the U.S. Department of Health and Human Services Office for Civil Rights after discovering that an unauthorized party had gained...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more
The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently submitted two annual reports to Congress setting forth a summary of complaints and breaches reported to the OCR during...more
On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for...more
On November 28, 2022, the U.S. Department of Health and Human Services (“HHS”) proposed sweeping changes to the rules that govern use and disclosure of protected health information (“PHI”) about patients receiving substance...more
Last week, the Federal Trade Commission (“FTC”) released two guidance documents to aid in compliance with its Health Breach Notification Rule (“the Rule”), which requires “vendors of personal health records” or “PHR related...more